April 2005 Issues

  Healthcare Information and Management Systems Society

Summary: Healthcare spending is up 5%-10% this year vs. 2004, with a similar increase expected in 2006. The key items on shopping lists: EMRs, PACS, and bar-coding. The federal government push for healthcare IT is viewed as mostly rhetoric at this point, but it is helping spur hospital IT investment, and eventually federally-mandated standards are considered likely. Cerner's focus appears to be on CPOE, but that's not where CIOs are focusing today. Eclipsys has improved slightly, but it is expected to be acquired by another company, not remain a standalone. Epic, which is expected to remain a standalone company, was praised by CIOs.

GE was described as the company to watch, but its weakness is its single-vendor approach. IDX got mixed reviews, with customers worried that its big U.K. contract will take funding and experts away from U.S. projects. McKesson is seen as "slightly improved" over last year, and it got good marks on implementation and service, but customers still report problems. Siemens appears to be holding its own, with its reputation unchanged and improved product, but flat market share.

  Cardiovascular Revascularization Therapies

Summary: Stent thrombosis was a hot topic, and doctors are keeping an eye on the issue, but most experts do not believe there is enough evidence at this point to prove Boston Scientific's Taxus has a problem. However, Taxus is starting to lose a little market share to Johnson & Johnson's Cypher, which continues to have supply problems. Doctors plan to use Medtronic's Endeavor if it gets approved because of the stent's handling, but they predicted it will be a niche product. Conor's CoStar stent is viewed as credible and probably the technology of the future, but sources insisted the data are still early. The importance of not stopping Sanofi-Aventis's Plavix too soon and of continuing aspirin for life in drug-eluting stent patients is becoming clearer. A more streamlined regulatory path is needed for modifications to approved drug-eluting stents, but the FDA is unlikely to shorten the process in the near future. There is a lot of interest in percutaneous valves, but the regulatory hurdles are high, and numerous other issues need to be overcome, making it 5-10 years before they are commonly performed.

  Mixed Votes at FDA Advisory Committee on Silicone Breast Implants

Summary: An FDA Advisory Committee gave the FDA mixed advice on what to do about silicone breast implants. The panel recommended against approval of Inamed's devices, criticizing the company's data collection, predictions for ruptures, and rupture explanations. However, panel members also recommended approval of Mentor's silicone breast implants - with conditions - praising Mentor's data collection, even though the data was shorter-term. It's starting to look likely that silicone breast implants will eventually gain approval; the question is simply one of timing. Is the FDA too risk averse to approve them this year? Perhaps, but sources doubt the Agancy will approve one device and not the other, predicting either both get approved or both get turned down again.

  International Myeloma Workshop

Summary: Celgene has a winner in Revlimid, which is almost certainly approvable. The DVTs and cardiac side effects make Revlimid not as clean as originally thought. Use of Millennium's Velcade will take a hit initially when Revlimid is approved because Revlimid is easier to administer and will probably be less expensive - but every mulitple myeloma patient will eventually get both of these drugs. Use of Celgene's Thalomid (thalidomide) will be more affected by Revlimid in the U.S. than in Europe. In the U.S., doctors are eager to move Revlimid ahead of thalidomide, but in Europe, cost will triage the three drugs (thalidomide, Revlimid, and Velcade - in that order). Combination therapy is the future. Eventually, doctors expect to give Volcade+Revlimid+something else. Treatment of myeloma may become like treating HIV - a cocktail that makes it a chronic disease.

  American College of Cardiology: Drugs

Summary: Sanofi-Aventis's diet drug Acomplia continues to look like a winner, and demand is likely to be high among cardiologists. Sanofi-Aventis's Plavix got a boost at ACC: adding it to a fibrinolytic+aspirin is an effective and safe way to reduce ischemic complications, and doubling the loading dose to 600 mg before stenting cuts the MI risk in half. Lilly's prasugrel could become a major challenger to Plavix. Though development is still early, it appears to be a much more powerful platelet inhibitor than Plavix. Prescriptions for Pfizer's Lipitor may go up after the results of the TNT trial, which proved lowering LDL cholesterol levels below current guidelines reduces the risk of heart attacks and strokes. Data are building that Pfizer's torcetrapib, a CETP inhibitor, raises HDL both as monotherapy and in combination with a statin, but Pfizer reportedly only plans to offer it in combination with Lipitor. The thing to watch with torcetrapib is the systolic blood pressure.

  American Society for Clinical Pharmacology and Therapeutics

Summary: The ASCPT meeting offered incremental but interesting new information on several drugs in development, including: Sanofi-Aventis's Ambien MR, MDS's transdermal fentanyl patch, Novartis's LAF-237 for diabetes, AstraZeneca's AZD-0865 (a potassium-competitive acid blocker that could be a first-in-class replacement for Nexium), Wyeth's desvenlafaxine-SR, and more.